Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT02166099

Conditions

Pancreatico-biliary Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Choledochoscopy using Digital Spyglass

Study Details

Brief summary:

The purpose of this registry is to record information and evaluate the impact of SpyGlassTM Direct Visualization System for choledochoscopy on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by SpyGlass.

This multi-center registry has been initiated:

  • To document the impact of SpyGlass Choledochoscopy in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies.
  • To assess the sensitivity, specificity, accuracy, technical feasibility, safety and cost effectiveness of SpyGlass and compare it to other diagnostic modalities.

Conditions

Pancreatico-biliary Disorder

Study ID

NCT02166099

Start date

Oct, 2012

Status verified date

Feb, 2017

Completion date

Dec 30, 2018

Anticipated

Primary completion date

Dec 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder
  • Above 18 years of age

Exclusion Criteria:

  • Any patient who has not undergone choledochoscopy for pancreatico-biliary disorders
  • Below 18 years of age

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

SpyGlass Choledochoscopy procedure

Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder

Interventions

Choledochoscopy using Digital Spyglass

Choledochoscopy using Digital Spyglass during Endoscopy

Primary outcome measure

  • Clinical Management [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Michel Kahaleh, MD

646-962-4797mik9071@med.cornell.edu

Monica R Gaidhane, MPH

646-962-4796mog2012@med.cornell.edu

Locations

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Contacts

Michel Kahaleh, MD

646-962-4797mkahaleh@gmail.com

Monica R Gaidhane, MD, MPH

646-962-4796mog2012@med.cornell.edu

Principal Investigator:

Michel Kahaleh, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 20, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2017-02-20.